UNISURGE TISSUE COLLECTION SYSTEM FOR ENDOS SURG— 510(k) K914922
Substantially EquivalentCharles L. Rose and Co., Inc.
FDA 510(k) clearance K914922 for UNISURGE TISSUE COLLECTION SYSTEM FOR ENDOS SURG, Substantially Equivalent on 1992-03-26. Applicant: Charles L. Rose and Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Charles L. Rose and Co., Inc.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
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More clearances from Charles L. Rose and Co., Inc.
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.